gabapentin

Generic: gabapentin

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gabapentin
Generic Name gabapentin
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

gabapentin 900 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-357
Product ID 68382-357_898c1710-d86c-4fbe-9a53-34661fcdb63a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203934
Listing Expiration 2026-12-31
Marketing Start 2025-09-18

Pharmacologic Class

Physiologic Effect
decreased central nervous system disorganized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68382357
Hyphenated Format 68382-357

Supplemental Identifiers

RxCUI
1806380 1806382 2634743 2634747 2634751
UPC
0368382607164
UNII
6CW7F3G59X
NUI
N0000008486

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gabapentin (source: ndc)
Generic Name gabapentin (source: ndc)
Application Number ANDA203934 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 900 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-357-01)
  • 60 TABLET in 1 BOTTLE (68382-357-14)
source: ndc

Packages (2)

68382-357-01 100 TABLET in 1 BOTTLE (68382-357-01) 68382-357-14 60 TABLET in 1 BOTTLE (68382-357-14)

Ingredients (1)

gabapentin (900 mg/1)

Linked Drug Pages (1)

gabapentin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "898c1710-d86c-4fbe-9a53-34661fcdb63a", "openfda": {"nui": ["N0000008486"], "upc": ["0368382607164"], "unii": ["6CW7F3G59X"], "rxcui": ["1806380", "1806382", "2634743", "2634747", "2634751"], "spl_set_id": ["3cfd04ab-e421-441f-a10e-e4dd1412974d"], "pharm_class_pe": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-357-01)", "package_ndc": "68382-357-01", "marketing_start_date": "20250918"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68382-357-14)", "package_ndc": "68382-357-14", "marketing_start_date": "20250918"}], "brand_name": "gabapentin", "product_id": "68382-357_898c1710-d86c-4fbe-9a53-34661fcdb63a", "dosage_form": "TABLET", "pharm_class": ["Decreased Central Nervous System Disorganized Electrical Activity [PE]"], "product_ndc": "68382-357", "generic_name": "gabapentin", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "gabapentin", "active_ingredients": [{"name": "GABAPENTIN", "strength": "900 mg/1"}], "application_number": "ANDA203934", "marketing_category": "ANDA", "marketing_start_date": "20250918", "listing_expiration_date": "20261231"}